Organon commissioned an independent analysis in partnership with Charles River Associates to work with a group of national and international biosimilar experts to identify the optimal, sustainable biosimilar policies and to develop actionable policy recommendations to improve biosimilar sustainability for a wide set of countries.

What is a Biosimilar?

A biosimilar is a biologic medicine that has been developed to be highly similar to an already approved biologic, or reference biologic. Biologics are complex in structure and generally expensive to manufacture. A biosimilar must go through a rigorous approval process to demonstrate there are no clinically meaningful differences in safety, purity or potency, compared to the reference biologic.

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Report Methodology

A literature review was undertaken to develop a 'sustainability scorecard' of 10 elements that characterise a sustainable environment for biosimilars. Country policy landscape assessments were then conducted, and followed by two international advisory boards to inform the development of actionable policy recommendations.

  • Sustainability Scorecard

    1

  • Market Assessments

    2
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    Advisory
    Board

  • Policy Recommendation Development

    3

CRA Literature Review

Expert Validation

Sustainability is seen as a significant issue for biosimilars due to:

  • Variation in biosimilar uptake
  • Country confidence
  • Uncertainty regarding biosimilar practices and policy
  • Conflation of the application of policy issues to biosimilars and generic small molecules
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Biosimilar Policy Sustainability Elements

These elements were selected as an objective rating system to evaluate the level of sustainability of biosimilar policy environment in
each market.

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  • Ensure safe and high-quality medicines

  • Facilitate cost savings for healthcare providers

  • Ensure healthy levels of supply

  • Maintain incentives for continued biologic research & innovation

  • Mitigate against biosimilar misconceptions

  • Facilitate efficient & streamlined patient access

  • Encourage multi-stakeholder decision-making

  • Facilitate sustainable levels of biosimilar competition

  • Increase prescribing options for patients & healthcare professionals

  • Maintain predictable market functioning

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See How Sustainable Biosimilar Policies Stack Up Worldwide

Choose one policy to compare up to 3 countries at a time. Clear selections with the reset button below.

Select the Policy:

  • Please Select
  • Manufacturing and R&D
  • Regulatory Approval
  • Health Technology Assessment
  • Pricing and Reimbursement
  • Contracting
  • Biosimilar Education and Understanding
  • Prescribing
  • Dispensing
  • Monitoring

Select up to Three Countries:

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*Please ensure only three options are selected at a time

Results:

Please select a Policy and Country to see the result.

SCALE LEGEND

Learn More about Biosimilar Policies Around the World

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This paper seeks to address three key questions:

  • Can we define an ‘ideal’ biosimilar policy toolkit that will ensure long term sustainability that is applicable across different market circumstances, across different types of biosimilars?
  • To what extent does existing biosimilar policy across a global selection of countries promote a long term sustainable environment benefitting all stakeholders?
  • Can we provide countries with tangible and actionable recommendations for meaningful improvements to the biosimilar sector applicable to different types of biosimilars?
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